A Clinical Study to Evaluate the Efficacy and Safety of D-2570 in the Treatment of Moderate to Severe Plaque Psoriasis

NCT07326813 | Recruiting Phase 3

• 1 other identifier: D2570-302
• Study Type: interventional
• Target: 477
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, double-blind, placebo- and active-controlled multicenter clinical trial involving patients with moderate to severe plaque psoriasis. Safety and efficacy assessments will be conducted during the scheduled study visits throughout the trial. After completing the respective treatment, all subjects will undergo a safety follow-up. Both the investigators and subjects will remain blinded throughout the entire treatment period. During the study, subjects are required to provide blood samples for pharmacokinetic (PK) and pharmacodynamic (PD) analyses at the time points specified in the trial protocol.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (3)

• To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

  Psoriasis Area and Severity Index (PASI)

  Treatment for 16 weeks after enrollment

• To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

  Physician Global Assessment (PGA)

  Treatment for 16 weeks after enrollment

• To evaluate the efficacy of different doses of D-2570 compared with placebo in the treatment of patients with moderate to severe plaque psoriasis

  Dermatology Life Quality Index (DLQI)

  Treatment for 16 weeks after enrollment

Secondary Outcomes (12)

• To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

  Treatment for 16 weeks after enrollment

• To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

  Treatment for 16 weeks after enrollment

• To evaluate the efficacy of different doses of D-2570 compared with BMS-986165 in the treatment of patients with moderate to severe plaque psoriasis

  Treatment for 16 weeks after enrollment

• To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

  Through study completion, an average of 28 weeks

• To evaluate the safety of different doses of D-2570 in the treatment of patients with moderate to severe plaque psoriasis

  Through study completion, an average of 28 weeks

Study Arms (4)

Evaluate the efficacy of different doses of D-2570 compared with placebo

EXPERIMENTAL

Drug: D-2570 Tablet; Drug: Placebo

Evaluate the efficacy of different doses of D-2570 compared with BMS-98165

ACTIVE COMPARATOR

Drug: D-2570 Tablet; Drug: BMS-986165 Tablet

Evaluate the safety of D-2570 treatment at different dosages

EXPERIMENTAL

Drug: D-2570 Tablet

Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis

EXPERIMENTAL

Drug: D-2570 Tablet

Interventions

D-2570 Tablet DRUG

D-2570 is a novel inhibitor targeting the TYK2 pseudokinase domain

Evaluate the efficacy of different doses of D-2570 compared with BMS-98165; Evaluate the efficacy of different doses of D-2570 compared with placebo; Evaluate the pharmacokinetics and pharmacodynamics of D-2570 in patients with plaque psoriasis; Evaluate the safety of D-2570 treatment at different dosages

BMS-986165 Tablet DRUG

BMS-986165 is a novel inhibitor targeting TYK2

Evaluate the efficacy of different doses of D-2570 compared with BMS-98165

Placebo DRUG

A placebo refers to a tablet that has no therapeutic effect on medication

Evaluate the efficacy of different doses of D-2570 compared with placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient voluntarily participates in this study after providing fully informed consent, signs a written informed consent form, and agrees to comply with the procedures specified in the study protocol;
• Aged between 18 and 70 years old (inclusive) at the time of signing the informed consent form, regardless of gender;
• The investigator assesses that the subject has plaque psoriasis suitable for systemic therapy, and the condition has been stable for ≥ 6 months before signing the informed consent form;
• At the screening stage and Day 1 (D1) of the treatment period, the Psoriasis Body Surface Area (BSA) is ≥10%, the Physician Global Assessment (PGA) score is ≥ 3 points, and the Psoriasis Area and Severity Index (PASI) score is ≥ 12 points;
• Hematology, Blood chemistry and Urinalysis examination were basically normal;
• Male subjects and female subjects of childbearing potential must agree to abstain from sexual intercourse or adopt effective contraceptive measures from the time of signing the informed consent form (ICF) until 30 days after the last administration of the investigational product.

You may not qualify if:

• Suffering from any type of psoriasis including erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, inverse psoriasis, or drug-induced psoriasis;
• Having other skin lesions that may interfere with the assessment of treatment outcomes, such as eczema;
• A history of severe herpes zoster/simplex infection;
• A history of tuberculosis, active tuberculosis, latent tuberculosis, or clinical manifestations suggestive of tuberculosis infection
• Having language barriers, or being unwilling or unable to fully understand and cooperate;
• Being pregnant or lactating women;
• Other circumstances that the investigator deems unsuitable for the subject to participate in the study.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

RECRUITING

MeSH Terms

Interventions

deucravacitinib

Central Study Contacts

Bingxin Xue

CONTACT

(86)21-50663661; bingxin.xue@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 8, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): July 12, 2027
• Study Completion (Estimated): December 3, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)